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CTRI Number  CTRI/2024/09/074089 [Registered on: 20/09/2024] Trial Registered Prospectively
Last Modified On: 13/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   prospecitve 
Study Design  Other 
Public Title of Study   Left atrial appendage systolic velocity correlation with post operative atrial fibrillation 
Scientific Title of Study   The relationship of left atrial appendage peak systolic velocity with the incidence of postoperative atrial fibrillation in patients undergoing cardiac surgery - A prospective observational study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Grace Aiswarya Jasmin David 
Designation  Senior resident in Cardiac Anaesthesiology 
Affiliation  All India institute of medical science, Bhubaneswar, Odisha 
Address  Department of Anaesthesiology and critical care, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  7708061355  
Fax    
Email  gjgrace16@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Prasanta Kumar Das 
Designation  Associate professor  
Affiliation  All India institute of medical science, Bhubaneswar, Odisha 
Address  Department of Anaesthesiology and critical care, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  7011469936  
Fax    
Email  anaes_prasanta@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Grace Aiswarya Jasmin David 
Designation  Senior resident in Cardiac Anaesthesiology 
Affiliation  All India institute of medical sciences, Bhubaneswar, Odisha 
Address  Department of Anaesthesiology, Cardiac Anaesthesiology, first floor, cardiothoracic and vascular surgery complex, All India institute of medical sciences, Sijua, Patrapada, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  7708061355  
Fax    
Email  gjgrace16@gmail.com  
 
Source of Monetary or Material Support  
Department of Cardiac Anaesthesia, All India institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha, India- 751019 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Grace Aiswarya Jasmin D  AIIMS Bhubaneswar  Department of Cardiac Anaesthesiology, cardiothoracic vascular surgery operation theatre, sijua, Patrapada, Bhubaneswar, Odisha, 751019
Khordha
ORISSA 		 7708061355

gjgrace16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committee AIIMS Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I088||Other rheumatic multiple valve diseases, (2) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (3) ICD-10 Condition: Q219||Congenital malformation of cardiacseptum, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • Scheduled to undergo cardiac surgery under cardiopulmonary bypass
• In Sinus rhythm in the preoperative period 
 
ExclusionCriteria 
Details  • Patient refusal for study
• Preexisting AF
• Previous procedure involving LAA
• Emergency / redo surgery
• Contraindication for TEE 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The incidence of post operative atrial fibrillation.  Baseline ECG and ECG monitoring throughout the period of ICU stay 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation of left atrial diameter, peak systolic velocity of mitral valve, average E, e’, E/A, E/e’, a’, LAVI & VIS with peak systolic velocity of LAA in the occurrence of post operative atrial fibrillation.  Baseline ECG before the surgery & ECG monitoring throughout the period of ICU stay 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [gjgrace16@gmail.com].

  6. For how long will this data be available start date provided 01-01-2028 and end date provided 01-01-2040?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The incidence of POAF is a common occurrence following cardiac surgery therefore, early identification of its occurrence would warrant health care providers to be proactive in treating the common causes of atrial fibrillation (AF) in the immediate post operative period. Since no other study as far as we have searched has worked on studying the correlation between peak systolic velocity of left atrial appendage (LAA) and the incidence of POAF, this study will be conducted. 


  1. Methodology of measuring Primary objective: 

    1. A 6VT TEE probe will be inserted and echocardiography images will be obtained with GE Vivid E95 Echocardiography machine (GE Vingmed Ultrasound, Horten, Norway) according to the surgical procedure with the aid of standard TEE guidelines. 

    2. In mid-esophageal two chamber view (ME 2C) view, the LAA will be identified as a claw- like structure arising from the left atrium. Pulsed wave doppler (PWD) will then be applied with the sample volume taken at one‐third length of the LAA from its base11. The peak positive wave will be measured as peak systolic velocity which is synonymous with LAA peak emptying velocity . Three consecutive values will be taken and averaged. Readings will be taken before sternotomy and after weaning off CPB. 

    3. Patients will be followed up in ICU and till the day of discharge. AF will be diagnosed upon the detection of abnormality in rhythm electrocardiogram (ECG), that is sustained for a minimum of 30 seconds and characterised by sustained arrhythmia, absent P waves, irregular R-R intervals and different intervals between atrial contractions (cycle < 200 ms). 

    4. Statistical analysis: 

      • Receiver-operating characteristic (ROC) analysis will be used to determine optimal cutoff valuesof continuous variables for prediction of POAF.

      • The area under the ROC curve will be used to quantify the ability of the PSV of LAA to predictincidence of POAF accurately.

      • Regression analysis will be used for all possible confounding factors and to assess interaction between variables for assessment of POAF. 

 
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